01 1Oranomed
01 1U.S.A
01 1Active
01 1Blank
01 1Blank
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32094
Submission : 2017-09-20
Status : Active
Type : II
A Lead manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lead, including repackagers and relabelers. The FDA regulates Lead manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lead API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Lead supplier is an individual or a company that provides Lead active pharmaceutical ingredient (API) or Lead finished formulations upon request. The Lead suppliers may include Lead API manufacturers, exporters, distributors and traders.
click here to find a list of Lead suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
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